Dermatone SPF 30
- Product NDC
- 54414-048
- 11-digit product format
- 544140048
- Labeler code
- 54414
- Product ID
- 54414-048_32e594c6-6baf-91c3-e063-6394a90ae2a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Dermatone Labs LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-26
- Substance
- HOMOSALATE; OCTOCRYLENE; AVOBENZONE
- Active strength
- 7; 5; 1.8 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dermatone SPF 30
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 7 g/100mL |
| OCTOCRYLENE | 5 g/100mL |
| AVOBENZONE | 1.8 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 32e5bddf-a0b5-c511-e063-6294a90aaf66 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54414-048-01 | Dermatone SPF 30 | 89 mL in 1 TUBE | LOTION | 89 | 9 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE | Old East Main Co. | db876d34-1af9-4e0a-9e9a-32a8b00e9405 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE | Old East Main Co. | 2ea288fe-815d-4568-9592-55ea428448fa | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | cea1c223-c9d4-42ac-8c5b-c0ca647d57a1 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Old East Main Co. | 00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 8f4a6a31-2fae-42fe-924f-10237c59e791 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ef48288b-533f-4924-ba12-fc8cb83643d4 | 2026-03-02 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | e6976bf4-ad77-4953-858f-4a0ec7f4300c | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | b3d2da09-d9c9-4c27-82fe-a434ece2f099 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ba9331ef-3744-4072-80a2-af95c6f7ee05 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 1a53d8d5-e650-4825-8a3b-7cf42c36e3e5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 086dfda5-9fe7-46b4-9964-4977b86cfdd5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ce9a2139-c5c2-43e2-bd51-1f14ace594d9 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Bask SPF 40 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Surfside Skincare, Inc. dba Bask Suncare | 49a30877-e39f-46a3-e063-6394a90a8dd2 | 2026-03-02 | Warnings | M020 |
| Sunscreen SPF30 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | f6014a97-12d3-4f42-86de-866a206c6c06 | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30V | SPF30 BS VANILLA | Epic Laboratories, LLC | 02488aad-28be-4ffb-e063-6294a90ad01e | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30T | SPF30 BS TROPICAL | Epic Laboratories, LLC | 0286f94e-a2e8-b529-e063-6294a90ac08d | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30V | SPF30 BS ORIGINAL | Epic Laboratories, LLC | 1872eefd-d702-ac9f-e063-6294a90a24ef | 2026-03-02 | Warnings | M020 |
| JAYSUING White Birch Moisturizing Sunscreen Cream | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 4c174691-cc32-b2e4-e063-6294a90a0f73 | 2026-03-02 | Warnings | M020 |
| Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer | ZINC OXIDE | Kypris Beauty LLC | a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3 | 2026-02-27 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54414-048-01 | 54414004801 | 89 mL in 1 TUBE (54414-048-01) | 89 ml | 2022-06-26 | No | No | Current |